[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Notices]
[Page 68300-68301]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-29]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 68300]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-085-1]
Monsanto Co. and Forage Genetics International; Availability of
Petition and Environmental Assessment for Determination of Nonregulated
Status for Alfalfa Genetically Engineered for Tolerance to the
Herbicide Glyphosate
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Monsanto Company and
Forage Genetics International seeking a determination of nonregulated
status for alfalfa designated as events J101 and J163, which have been
genetically engineered for tolerance to the herbicide glyphosate. The
petition has been submitted in accordance with our regulations
concerning the introduction of certain genetically engineered organisms
and products. In accordance with those regulations, we are soliciting
public comments on whether this alfalfa presents a plant pest risk. We
are also making available for public comment an environmental
assessment for the proposed determination of nonregulated status.
DATES: We will consider all comments we receive on or before January
24, 2005.
ADDRESSES: You may submit comments by any of the following methods:
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-085-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-085-1.
E-mail: Address your comment to
regulations@aphis.usda.gov. Your comment must be contained in the body
of your message; do not send attached files. Please include your name
and address in your message and ``Docket No. 04-085-1'' on the subject
line.
Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html
for a form you can use to submit an e-mail comment through
the APHIS Web site.
Reading Room: You may read the petition, the environmental
assessment, and any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Virgil Meier, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-3363. To obtain copies of the petition or the
environmental assessment (EA), contact Ms. Terry Hampton at (301) 734-
5715; e-mail: Terry.A.Hampton@aphis.usda.gov. The petition and the EA
are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_11001p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_11001p_ea.pdf.
SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,
``Introduction of Organisms and Products Altered or Produced Through
Genetic Engineering Which Are Plant Pests or Which There Is Reason to
Believe Are Plant Pests,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason to
believe are plant pests. Such genetically engineered organisms and
products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
On April 16, 2004, APHIS received a petition from Monsanto Company
of St. Louis, MO, and Forage Genetics International of West Salem, WI
(Monsanto/FGI), requesting a determination of nonregulated status under
7 CFR part 340 for alfalfa (Medicago sativa L.) designated as events
J101 and J163, which have been genetically engineered for tolerance to
the herbicide glyphosate. The Monsanto/FGI petition states that the
subject alfalfa should not be regulated by APHIS because it does not
present a plant pest risk.
As described in the petition, alfalfa events J101 and J163 have
been genetically engineered to express a 5-enolpyruvyshikimate-3-
phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4
EPSPS), which confers tolerance to the herbicide glyphosate. Expression
of the added genes is controlled in part by the 35S promoter derived
from the plant pathogen figwort mosaic virus. The Agrobacterium
tumefaciens transformation method was used to transfer the added genes
into the proprietary alfalfa line R2336.
Alfalfa events J101 and J163 have been considered regulated article
under the regulations in 7 CFR part 340 because they contain gene
sequences from plant pathogens. In the process of reviewing the
notifications for field trials of the subject alfalfa, APHIS determined
that the vectors and other elements were disarmed and that the trials,
which were conducted under conditions of reproductive and physical
confinement or isolation, would not present a risk of plant pest
introduction or dissemination.
In section 403 of the Plant Protection Act (7 U.S.C. 7701-7772),
plant pest is
[[Page 68301]]
defined as any living stage of any of the following that can directly
or indirectly injure, cause damage to, or cause disease in any plant or
plant product: A protozoan, a nonhuman animal, a parasitic plant, a
bacterium, a fungus, a virus or viroid, an infectious agent or other
pathogen, or any article similar to or allied with any of the
foregoing. APHIS views this definition very broadly. The definition
covers direct or indirect injury, disease, or damage not just to
agricultural crops, but also to plants in general, for example, native
species, as well as to organisms that may be beneficial to plants, for
example, honeybees, rhizobia, etc.
The U.S. Environmental Protection Agency (EPA) is responsible for
the regulation of pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA
requires that all pesticides, including herbicides, be registered prior
to distribution or sale, unless exempt by EPA regulation. In cases in
which genetically modified plants allow for a new use of a pesticide or
involve a different use pattern for the pesticide, EPA must approve the
new or different use. Accordingly, Monsanto/FGI are seeking
registration for the use of glyphosate on glyphosate-tolerant alfalfa
from the EPA.
When the use of the pesticide on the genetically modified plant
would result in an increase in the residues in a food or feed crop for
which the pesticide is currently registered, or in new residues in a
crop for which the pesticide is not currently registered, establishment
of a new tolerance or a revision of the existing tolerance would be
required. Residue tolerances for pesticides are established by EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21
U.S.C. 301 et seq.), and the Food and Drug Administration (FDA)
enforces tolerances set by EPA under the FFDCA. EPA is currently
evaluating the residue tolerance for glyphosate-tolerant alfalfa.
FDA published a statement of policy on foods derived from new plant
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005).
The FDA statement of policy includes a discussion of FDA's authority
for ensuring food safety under the FFDCA, and provides guidance to
industry on the scientific considerations associated with the
development of foods derived from new plant varieties, including those
plants developed through the techniques of genetic engineering.
Monsanto/FGI has begun consultation with FDA on the subject alfalfa
event.
To provide the public with documentation of APHIS' review and
analysis of the environmental impacts and plant pest risk associated
with a proposed determination of nonregulated status for the Monsanto/
FGI events J101 and J163 alfalfa, an environmental assessment (EA) has
been prepared. The EA was prepared in accordance with (1) The National
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
In accordance with Sec. 340.6(d) of the regulations, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the petition for a determination of
nonregulated status from interested persons for a period of 60 days
from the date of this notice. We are also soliciting written comments
from interested persons on the EA prepared to examine any environmental
impacts of the proposed determination for the subject alfalfa event.
The petition and the EA and any comments received are available for
public review, and copies of the petition and the EA are available as
indicated in the FOR FURTHER INFORMATION CONTACT section of this
notice.
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. After reviewing and
evaluating the comments on the petition and the EA and other data and
information, APHIS will furnish a response to the petitioner, either
approving the petition in whole or in part, or denying the petition.
APHIS will then publish a notice in the Federal Register announcing the
regulatory status of the Monsanto/FGI glyphosate-tolerant alfalfa
events J101 and J163 and the availability of APHIS' written decision.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 18th day of November 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E4-3315 Filed 11-23-04; 8:45 am]
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